Health Trials

About this trial

This is a Phase 1b study to assess the safety, tolerability, PK, and PD of investigational phage therapy (IP) in adults with SCI and bladder colonization (ASB). It is a single-center, randomized, double-blind, placebo-controlled study in adults with SCI with neurogenic bladders and bacteriuria who use indwelling catheters, or who require intermittent catheterization for bladder drainage.

Eligibility criteria

Qualifiers

Provision of signed and dated informed consent form.

Stated willingness to comply with all study procedures and availability for the duration of the study.

Adult (> age 18) with a diagnosis of Spinal Cord Injury/Disease (SCI/D) and neurogenic bladder. Eligible participants may include inpatients in the SCI care unit or outpatients receiving care at participating sites, regardless of the underlying cause of SCI (e.g., trauma, tumors or demyelinating).

ASB with E. coli present in a quantity of ≥ 104 CFU/mL.

Disqualifiers

Unable to provide informed consent for themselves.

Received a new antibiotic expected to kill the Gram-negative organisms in the urine between initial enrollment urine culture and the time of randomization.

History of neutropenia, defined by ANC < 1000 per µL within 6 months prior to screening.

History of organ transplantation.

Trial design

Treatments tested in this trial

  • Phage Therapy
  • Placebo

Treatment groups

30 Participants
are divided into 2 treatment groups

Locations

2
Washington University in St Louis63110, St LouisMissouri, United States
Michael E. DeBakey VA Medical Center77030, HoustonTexas, United States

Sponsors and collaborators

Barbara Trautner

Lead sponsor

Washington University School of Medicine

Sponsor institution

Source ClinicalTrials.gov